Thanks to everyone for the valuable information provided here. I've had Hep B for 8 yrs and on ent for 7 yrs. I sero converted to e-antigen negative after 7 months and DNA is undetectable. After reading about the S antigen quantitative test not being available in the US, I started emailing labs and doctors to see if anyone knew where to get this test done. One of the top liver specialists at Georgetown University Hospital in DC emailed that according to his sources, "several companies are due to have their HBsAG quantitative test approved by the FDA in the coming months and we may hear about it in the near future". From what I've read on this forum, I would assume Roche and Abbott would be the companies. So maybe some good news for those of us in the States.
I contacted the liver specialist at Georgetown and he had no further info or reason for this still not being approved. Then I contacted Sen. Tim Kaine's office and asked if they could find out from the FDA when this would be approved. FDA gave a ridiculous answer that they couldn't even confirm if the test is under consideration for approval as it might give one company or another some type of financial advantage. Go figure.
I don't think that the labs here in USA need the FDA's approval to run this test. When i looked on Labcorps website for the HBV Genotype test i found this comment on the bootom of the page:
Limitations This assay may not be successful when the HBV viral load is <500 IU/mL.
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
I emailed them regarding this and surprisingly got a very long response back with their explanation that it's not clinically necessary. I found some research papers concluding that in fact it is and sent it back to them. All they said was basically thanks but no.
So what is the real reason we don't have this test here?
My doctor told me that they feel hbsag quant is useless and FDA will not approve. They say it has no meaning. I live in the USA and not being able to get hbsag quant test is ridiculous. almost the whole world is able to test hbsag quant. the insurance , medical industry and food industry is the most corrupt in the US. food farming industry is so corrupt in the usa its ridiculous.
Scantibodies in California will do the test on research basis for $1,780.00,
they said they don't run this test often and would have to order the reagents in order to do it.
I can't imagine the reagents would cost that much.
For the quoted price we could take a trip to Europe, get it done, and have some fun! Even if we get it done what will doctors do with it back in the US, since they only care about DNA? Corrupt system for sure here when it comes to HBV.
even if our hbsag quant was less than 200iu/ml , Doctors in the US would still deny us PEG. In the US we estimate only 2.5 million hep b carriers but i guarantee we pay more for nucs then the estimated 350 million in china.
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